Ebola crisis requires hastened FDA approval

During the standard FDA approval process for vaccines and drugs, years go by before anything tangible reaches the general public. However, in an attempt to treat the Ebola epidemic sweeping an entire continent, the World Health Organization has cut that time short and has urged a rapid release of treatments to those areas in need. This decision, although severe, gives a sliver of hope for survival to the individuals living within infected regions.

With hundreds dying everyday and cases doubling every few weeks to an predicted 20,000 incidences by November, time is running thin. Prematurely releasing these medications gives rise to many ethical debates, all of which seem to be trumped by the undeniable notion that action needs to be taken regardless of the risk associated with hasty clinical trials. In an area where safety is normally of prime concern, this priority must be sacrificed to explore the potential of saving lives.

Yet this decision does raise issues of distribution and of the true efficacy of the drugs. Without a structured control group, uncertainty will surround the effectiveness of the vaccine. But in such an urgent situation, one cannot simply leave out a certain suffering population in order to determine the workings of the drug.

In addition, health specialists would still need to make sure individuals participating in the trials maintained precautions, forcing them to question whether it was the protective measures taken or the vaccine itself that caused a person to avoid the disease.

Furthermore, the speed does not take into account the expertise required of the locals to maintain the integrity of their own health. In highly communal regions, empathy and love can lead to transmission of the disease and even death. In addition to the release of the treatments, more measures should be taken to educate areas about the disease, its means of transmission and how to prevent its spread in locations with low hygienic properties.

To combat some of these hindrances, the W.H.O. has decided to convene a meeting to discuss answers to these questions and does not plan on conducting a trial in the area before January. So despite the downsides, the best is being done with the available resources.

But in a battle with death, any weapon of defense is better than solemn surrender and acceptance of that gruesome fate

Faizah Shareef is a senior majoring in exercise physiology.


October 9, 2014


Faizah Shareef

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